510(k) · Cleared
ClearedNextDent Denture 3D+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vertex-Dental B.V. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Nov 1, 2019 as substantially equivalent to K162572 (Vertex-Dental B.V., 2017) after a 149-day review. Its family tree reaches back 4 generations to 2001. 13 later devices descend from it.
- Decided
- Nov 1, 2019
- Review
- 149 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011560 (2001). 13 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK011560 Trubyte Denture Base Resin SystemDentsply Intl. · 2001
- 3 generations backK032892 Modification to Trubyte Denture Base Resin SystemDentsply Intl. · 2003
- 2 generations backK143033 Dentca Denture BaseDentca, Inc. · 2015
- 1 generation backK162572 NextDent Denture, E-DentureVertex-Dental B.V. · 2017
- This deviceK191497 NextDent Denture 3D+Vertex-Dental B.V. · 2019
- Descendant · cites it directly · 3 of its ownK210298 GR-14 Resin SystemPro3Dure Medical GmbH · 2021
- Descendant · cites it directly · 3 of its ownK203641 E-Denture ProEnvisiontec GmbH · 2021
- Descendant · 2 generations on · 2 of its ownK241089 KeyPrint KeyDenture BaseKeystone Industries · 2024
- Descendant · 2 generations on · 2 of its ownK213765 Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK250489 FP3DKeystone Industries · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K210298GR-14 Resin SystemPro3Dure Medical GmbH · 2021 · cites it directly3descendants
- K203641E-Denture ProEnvisiontec GmbH · 2021 · cites it directly3descendants
- K241089KeyPrint KeyDenture BaseKeystone Industries · 2024 · 2 generations on2descendants
- K213765Glidewell 3DP Denture Base ResinPrismatik Dentalcraft, Inc. · 2022 · 2 generations on2descendants
- K250489FP3DKeystone Industries · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011560 | Trubyte Denture Base Resin System | Dentsply Intl. | 2001 | — |
| −3 | K032892 | Modification to Trubyte Denture Base Resin System | Dentsply Intl. | 2003 | — |
| −2 | K143033 | Dentca Denture Base | Dentca, Inc. | 2015 | — |
| −1 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017 | — |
| 0 (this device) | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019 | — |
| +1 | K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | 2021 | — |
| +1 | K203641 | E-Denture Pro | Envisiontec GmbH | 2021 | — |
| +2 | K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024 | — |
| +2 | K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022 | — |
| +3 | K250489 | FP3D | Keystone Industries | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162572 | NextDent Denture, E-DentureSummary page 4…cation Name(s): Classification #: 21 CFR 872.3760 Product Code EBI Regulatory Class 2 III. PREDICATE NextDent Denture, K162572 DEVICE(s) No reference devices were used in this submission. IV. DEVICE DESCRIPTION Device Identificat… | 2017 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K210298 (Pro3Dure Medical GmbH, 2021) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K162572.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
NextDent Denture 3D+ is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent Denture 3D+ is intended exclusively for professional dental work. Fabrication of denture bases with NextDent Denture 3D+ requires a computer-aided and manufacturing (CAD/CAM) system that…
Read the full statement (109 words)
NextDent Denture 3D+ is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent Denture 3D+ is intended exclusively for professional dental work. Fabrication of denture bases with NextDent Denture 3D+ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following scanner, design software, additive printer and post-cure unit:
Design:
Brand Type Software
Scanner 3Shape D900
Design software 3Shape Dental-System 2016 Premium
Printing:
Brand Type Software
Printer 3D Systems NextDent 5100 Figure4® 3D Sprint
Post-curing:
Brand Type Software
Post-cure unit NextDent LC-3DPrint Box n.a.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191497 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191497: NextDent Denture 3D+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191497
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026